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Effect of Increased Intake of Low Fat Dairy Products on Weight Loss and Insulin Resistance

Not Applicable
Completed
Conditions
Impaired Glucose Tolerance
Type 2 Diabetes
Metabolic Syndrome
Interventions
Behavioral: High dairy and calcium intake
Behavioral: Usual intake
Registration Number
NCT00564551
Lead Sponsor
University of Calgary
Brief Summary

The purpose of this study is to determine if increased intake of low-fat milk products and calcium as part of a calorie restricted diet helps achieve a healthier body weight and body composition and decrease blood glucose levels in people with insulin resistance or type 2 diabetes.

Detailed Description

Obesity can cause many health problems as it is linked to several chronic diseases including type 2 diabetes. We know that individuals who are overweight or obese, and have impaired glucose tolerance or insulin resistance, have a good chance of developing type 2 diabetes. Research tells us that the risk of developing type 2 diabetes can be decreased by losing weight and making dietary changes. A promising area of study involves using low-fat milk products and calcium to prevent and/or control obesity and diabetes. This study is important because it will determine if including low-fat milk products in weight reducing diets can enhance weight loss, improve fat loss and decrease levels of blood glucose and insulin in individuals with impaired glucose tolerance or type 2 diabetes not treated with medication. This information is directly applicable to treating diseases such as obesity, type 2 diabetes and heart disease.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
49
Inclusion Criteria
  • Overweight and obese (BMI of 27 to 37 kg/m2)

  • Impaired glucose tolerance (fasting blood glucose >5.6 mmol/L) or

  • Type 2 diabetes treated with diet and exercise alone (no medications)

  • One or more of the following criteria for metabolic syndrome:

    1. Hypertriglyceridemia (> 1.70 mmol/L)
    2. Low high-density lipoprotein (HDL) cholesterol (< 1.04 mmol/L in men and < 1.30 mmol/L in women)
    3. High blood pressure (> 130/85 mm Hg)
    4. High waist circumference ( > 94 cm in men, > 80 cm in women)
  • Weight stable and no changes in exercise in past 3 months

Exclusion Criteria
  • Type 1 diabetes
  • Type 2 diabetes treated with oral hypoglycemic agents or insulin
  • HbA1c > 8%
  • myocardial infarction or have undergone a cardiovascular intervention within the past three months
  • Subjects taking fibrate or statins who have had a dose change within the 8 weeks prior to randomization
  • Liver or pancreas disease
  • Major gastrointestinal surgeries
  • Pregnant or lactating
  • Exhibit alcohol or drug dependence
  • Taking drugs influencing appetite
  • Have a milk allergy or lactose intolerance
  • Following a diet or exercise regime designed for weight loss
  • Have a body weight greater than 350 lb (weight limit for DEXA instrument)
  • Chronic use of bulk laxatives, antacids or calcium supplements

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2High dairy and calcium intakeHigh dairy intake and calcium supplement. High intake of low-fat milk product intake (3-4 servings per day) plus one 350 mg calcium supplement per day during 500 kcal/day deficit diet.
1Usual intakeUsual diet of low dairy and calcium intake. Usual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet.
Primary Outcome Measures
NameTimeMethod
Weight loss12 weeks
Secondary Outcome Measures
NameTimeMethod
Insulin and glucose response12 weeks
Inflammatory Markers12 weeks

Trial Locations

Locations (1)

Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research

🇨🇦

Calgary, Alberta, Canada

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